iTeos Therapeutics Announces Late-Breaking Oral Presentation of Phase 2 GALAXIES Lung-201 Interim Data at the European Society for Medical Oncology Congress 2024
iTeos Therapeutics (Nasdaq: ITOS) announced that interim data from the Phase 2 GALAXIES Lung-201 study will be presented at the European Society for Medical Oncology (ESMO) Congress 2024. The study, sponsored by iTeos' partner GSK, assesses the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer. The presentation, titled 'Interim Analysis of GALAXIES Lung-201,' is scheduled for September 14, 2024, at 8:30 am CEST as a late-breaking oral presentation. This Phase 2 randomized, open-label platform study focuses on patients with PD-L1 high (TPS ≥50%) NSCLC. The abstract will be published on the ESMO website at 00:05 am CEST on the day of the presentation.
iTeos Therapeutics (Nasdaq: ITOS) ha annunciato che i dati preliminari dello studio di Fase 2 GALAXIES Lung-201 saranno presentati al Congresso della Società Europea di Oncologia Medica (ESMO) 2024. Lo studio, sponsorizzato dal partner di iTeos GSK, valuta il combinato belrestotug + dostarlimab in casi di carcinoma polmonare non a piccole cellule avanzato localmente o metastatico con alta espressione di PD-L1 che non sono stati precedentemente trattati. La presentazione, intitolata 'Analisi Intermedia di GALAXIES Lung-201', è programmata per il 14 settembre 2024, alle 8:30 CEST come presentazione orale in ritardo. Questo studio di Fase 2 è randomizzato e a etichetta aperta, focalizzandosi su pazienti con NSCLC PD-L1 alto (TPS ≥50%). L'abstract sarà pubblicato sul sito web di ESMO alle 00:05 CEST nel giorno della presentazione.
iTeos Therapeutics (Nasdaq: ITOS) anunció que los datos preliminares del estudio de Fase 2 GALAXIES Lung-201 se presentarán en el Congreso de la Sociedad Europea de Oncología Médica (ESMO) 2024. El estudio, patrocinado por el socio de iTeos GSK, evalúa el doblete belrestotug + dostarlimab en cáncer de pulmón de células no pequeñas, localmente avanzado o metastásico, sin tratar previamente y con alta expresión de PD-L1. La presentación, titulada 'Análisis Intermedio de GALAXIES Lung-201', está programada para el 14 de septiembre de 2024, a las 8:30 am CEST como una presentación oral de última hora. Este estudio de Fase 2 es aleatorizado y de etiqueta abierta, enfocado en pacientes con NSCLC de alta expresión de PD-L1 (TPS ≥50%). El resumen se publicará en el sitio web de ESMO a las 00:05 am CEST el día de la presentación.
iTeos Therapeutics (Nasdaq: ITOS)는 2상 GALAXIES Lung-201 연구의 중간 데이터가 2024년 유럽종양학회(ESMO) 총회에서 발표될 것이라고 발표했습니다. 이 연구는 iTeos의 파트너인 GSK가 후원하며, 이전 치료를 받지 않은, 수술 불가능한, 국소 진행성 또는 전이성 PD-L1 고발현 비소세포폐암에서 belrestotug + dostarlimab 병용요법을 평가합니다. 발표 제목은 'GALAXIES Lung-201의 중간 분석'이며, 2024년 9월 14일 오전 8시 30분 CEST에 지연 발표로 예정되어 있습니다. 이 2상 무작위 개방형 연구는 PD-L1 고발현(NSCLC TPS ≥50%) 환자에 중점을 두고 있습니다. 초록은 발표 당일인 00:05 am CEST에 ESMO 웹사이트에 게시됩니다.
iTeos Therapeutics (Nasdaq: ITOS) a annoncé que les données intérimaires de l'étude de Phase 2 GALAXIES Lung-201 seront présentées au Congrès de la Société Européenne d'Oncologie Médicale (ESMO) 2024. L'étude, sponsorisée par le partenaire de iTeos GSK, évalue le doublet belrestotug + dostarlimab chez des patients non traités auparavant, inopérables, atteints d'un cancer du poumon non à petites cellules avancé localement ou métastatique, à fort taux de PD-L1. La présentation, intitulée 'Analyse Intermédiaire de GALAXIES Lung-201', est prévue pour le 14 septembre 2024, à 8h30 CEST sous forme de présentation orale de dernière minute. Cette étude de Phase 2 est randomisée et ouverte, axée sur les patients atteints de NSCLC à fort taux de PD-L1 (TPS ≥50%). Le résumé sera publié sur le site Web de l'ESMO à 00h05 CEST le jour de la présentation.
iTeos Therapeutics (Nasdaq: ITOS) gab bekannt, dass die Zwischendaten der Phase 2 GALAXIES Lung-201-Studie auf dem Europäischen Kongress für medizinische Onkologie (ESMO) 2024 präsentiert werden. Die Studie, die von iTeos' Partner GSK sponsort wird, bewertet die Kombination von belrestotug + dostarlimab bei früher nicht behandelten, resezierbaren, lokal fortgeschrittenen oder metastasierenden PD-L1-hohen nicht-kleinzelligen Lungenkrebs. Die Präsentation mit dem Titel 'Zwischenanalyse der GALAXIES Lung-201' ist für 14. September 2024, 8:30 Uhr CEST als späte mündliche Präsentation geplant. Diese Phase-2-Studie ist randomisiert und offen und konzentriert sich auf Patienten mit PD-L1 hohem (TPS ≥50%) NSCLC. Die Zusammenfassung wird am Tag der Präsentation um 00:05 Uhr CEST auf der ESMO-Website veröffentlicht.
- Phase 2 interim data to be presented at a major oncology conference (ESMO)
- Late-breaking oral presentation slot secured, indicating potentially significant results
- Study focuses on previously untreated patients, suggesting potential for first-line therapy
- Partnership with major pharmaceutical company GSK for drug development
- None.
Insights
The presentation of interim data from the GALAXIES Lung-201 Phase 2 study at ESMO 2024 is a significant milestone for iTeos Therapeutics and its partner GSK. This study, focusing on belrestotug + dostarlimab in PD-L1 high non-small cell lung cancer (NSCLC), could potentially reshape treatment paradigms in this challenging disease area.
The selection for a late-breaking oral presentation suggests that the results are likely to be impactful. NSCLC remains a leading cause of cancer-related deaths and new therapies targeting PD-L1 high patients could significantly improve outcomes. The combination of belrestotug (an ADCC-enhanced anti-TIGIT antibody) with dostarlimab (an anti-PD-1 antibody) represents a novel approach in immuno-oncology, potentially offering enhanced efficacy over current standards of care.
Investors should closely monitor this presentation, as positive data could substantially boost iTeos's market position and accelerate the path to potential regulatory submissions.
The GALAXIES Lung-201 study is particularly intriguing as it targets previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC patients. This population typically responds well to immunotherapy, but there's still room for improvement. The combination of belrestotug and dostarlimab could potentially offer a more potent immunotherapeutic approach.
Key aspects to watch for in the presentation include objective response rate, progression-free survival and safety profile. If the doublet shows superior efficacy to current first-line treatments like pembrolizumab monotherapy, with a manageable safety profile, it could quickly become a preferred option for this patient subset. The biomarker analysis will also be crucial, potentially identifying subgroups that benefit most from this combination.
This study could pave the way for a new standard of care in PD-L1 high NSCLC, a significant advancement in a field where progress has been incremental in recent years.
WATERTOWN, Mass. and GOSSELIES, Belgium, Aug. 20, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS) (“iTeos”), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today announced that interim data from GALAXIES Lung-201, the Phase 2 platform study sponsored by iTeos’ development partner GSK, assessing the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced or metastatic PD-L1 high non-small cell lung cancer, will be presented as a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024, being held September 13-17, 2024 in Barcelona, Spain.
Late Breaking Oral Presentation Details
Title: Interim Analysis of GALAXIES Lung-201: Phase 2, Randomized, Open-label Platform Study of Belrestotug Plus Dostarlimab in Patients (pts) With Previously Untreated Locally Advanced/Metastatic (LA/M) PD-L1 High (TPS >/=
Abstract Number: LBA52
Session Title: Proffered Paper Session: NSCLC Metastatic
Date / Time: September 14, 2024 at 8:30 am CEST / 2:30 am ET
The ESMO website indicates that all late-breaking abstracts will be published on the ESMO website on the day of the presentation at 00:05 am CEST.
About iTeos Therapeutics, Inc.
iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients. iTeos Therapeutics leverages its deep understanding of tumor immunology and immunosuppressive pathways to design novel product candidates with the potential to restore the immune response against cancer. The Company’s innovative pipeline includes three clinical-stage programs targeting novel, validated immunosuppressive pathways designed with optimized pharmacologic properties for improved clinical outcomes, including the TIGIT/CD226 axis and the adenosine pathway. iTeos Therapeutics is headquartered in Watertown, MA with a research center in Gosselies, Belgium.
About Belrestotug (EOS-448/ GSK4428859A)
Belrestotug is an Fc active human immunoglobulin G1, or IgG1, monoclonal antibody (mAb) targeting T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT), an important inhibitory receptor which contributes to the suppression of innate and adaptive immune responses against cancer. As an optimized high-affinity, potent anti-TIGIT mAb, belrestotug is designed to enhance the antitumor response through a multifaceted immune modulatory mechanism by engaging with TIGIT and FcγR, a key regulator of immune responses which induces cytokine release and antibody dependent cellular cytotoxicity (ADCC). The therapeutic candidate is progressing in multiple indications in collaboration with GSK.
Internet Posting of Information
iTeos routinely posts information that may be important to investors in the 'Investors' section of its website at www.iteostherapeutics.com. The Company encourages investors and potential investors to consult our website regularly for important information about iTeos.
For further information, please contact:
Investor Contact:
Carl Mauch
iTeos Therapeutics, Inc.
carl.mauch@iteostherapeutics.com
Media Contact:
media@iteostherapeutics.com
FAQ
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